Reported Jun 3, 2020 · Terminated

Lamotrigine Tablets, USP, 150 mg, 20,000-count bulk container, Manufactured by: Jubilant Cadista Pharmaceuticals Inc.,…

Jubilant Cadista Pharmaceuticals, Inc.

Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Jubilant Cadista Pharmaceuticals, Inc. · 207 Kiley Dr · Salisbury, MD · 21801-2249

Is this the product you have?

    • Lamotrigine Tablets
    • USP
    • 150 mg
    • 20
    • 000-count bulk container
  • Manufactured byJubilant Cadista Pharmaceuticals Inc., Salisbury, MD 21801, USA
  • For repackaging byAvKare Inc., Pulaski, TN 38478, Bulk Shipment, NDC 59746-247-97
Lot codes and dates
    • Lot #s 19P0437 & 19P0438
    • Exp. 09/30/2021
Amount recalled
1,313,333 tablets

Where it was sold

Why it was recalled

Presence of Foreign Substance visually consistent with the silica granules present in the desiccant packs utilized during storage of the product.

This product is unlikely to cause harm, but it breaks a safety or labelling rule.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Nov 15, 2022 · Data as of Sep 19, 5:55 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.